Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions

NCT07470827 | Active Not Recruiting DMC

• 1 other identifier: WAY-CTP-WME02
• Study Type: observational
• Target: 1,178
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the effectiveness of the computer-aided diagnosis (CADx) software, 'WAYMED endo CL CS', which assists medical specialists by automatically analyzing colorectal endoscopic images, identifying lesions, and providing probability values to classify them as Adenoma or Non-Adenoma. This pivotal trial is designed to confirm that 'WAYMED endo CL CS' can support clinicians in diagnostic decision-making by improving the classification of colorectal lesions.

Conditions

Colorectal Adenoma; Sessile Serrated Lesion; Hyperplastic Polyp; Carcinoma; Adenoma; Non-Adenoma

Keywords

Colorectal Endoscopy; Adenoma; Non-Adenoma; Artificial Intelligence; Computer-Aided Diagnosis (CADx); Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (2)

• Clinical Sensitivity in classifying colorectal lesions (%)

  The probability of being classified as "Adenoma" among colorectal endoscopic images confirmed as "Adenoma" through histopathology.

  6 months

• Clinical Specificity in classifying colorectal lesions (%)

  The probability of being classified as "Non-Adenoma" among colorectal endoscopic images confirmed as "Non-Adenoma" through histopathology.

  6 months

Secondary Outcomes (1)

• Diagnostic Accuracy in classifying colorectal lesions (%)

  6 months

Study Arms (2)

Trial group

Colorectal endoscopic images in this group are analyzed by WAYMED endo CL CS, which identifies lesions and classifies them as "Adenoma" or "Non-Adenoma" with probability values.

Device: WAYMED endo CL CS

Reference Standard

All lesions are verified by histopathology and annotated by the Reference Standard Establishment Committee (experienced endoscopy specialists). This serves as the comparator for evaluating diagnostic performance.

Other: Reference standard review

Interventions

WAYMED endo CL CS DEVICE

Classification of colorectal endoscopic images as "Adenoma" or "Non-Adenoma" by WAYMED endo CL CS (Computer-aided diagnosis software for colorectal endoscopy).

Trial group

Reference standard review OTHER

Colorectal endoscopic images are independently reviewed by expert endoscopists and confirmed with histopathology to establish the reference standard.

Reference Standard

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colorectal endoscopic images from adult patients (≥19 years) who underwent colonoscopy and biopsy, with confirmed histopathology results for Adenoma or Non-Adenoma lesions.

You may qualify if:

• Adult patients (≥19 years) with colorectal endoscopic images showing one lesion.
• Histopathology confirming the lesion as Adenoma (colorectal cancer, adenoma) or Non-Adenoma (sessile serrated lesion, hyperplastic polyp).

You may not qualify if:

• Images previously used for training or internal validation of the investigational software.
• History of colectomy.
• Diagnosed with inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or neuroendocrine tumor.
• Poor image quality (blurred, incomplete lesion capture).
• Images with multiple lesions or fewer than two images per lesion.

Sponsors & Collaborators

• WAYCEN Inc: lead

Study Sites (1)

Yonsei University Gangnam Severance Hospital

Seoul, Gangnam, 06273, South Korea

Location

MeSH Terms

Conditions

Carcinoma; Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

KR (1)